The term "ostomy" is derived from the Latin word stoma, which means opening. The medical term "ostomy" refers to a variety of conditions in which either urinary or intestinal waste products are eliminated through an opening in the anterior abdominal wall (front of the abdomen). This opening in the abdominal wall is created as part of a variety of surgical procedures for the treatment of a number of different medical conditions. A colostomy, for example, is a surgically created route that allows the contents of the lower large intestine to pass out through an opening in the lower abdominal wall. An ileostomy is a similar surgically created opening through which the contents of the small intestine or ileum are allowed to drain out of the body. Urinary diversions, similarly, are created when an alternate route for the elimination of urine is required either due to a congenital defect or as surgical treatment for a disease process. Examples of urinary diversions include ureterostomies, urinary conduits or ureteroileostomies, all of which are collectively known as urostomies.
Ostomy surgery of all types was developed approximately 35 years ago. Indications for this surgery and frequency of usage increased as surgical techniques improved. The surgically created external drainage of body waste requires an ostomy appliance, which is a receptacle for the collection of these wastes. The design and function of current ostomy appliances is based on their initial development over 30 years ago. Individuals now receive ostomy surgery with greater frequency, and these individuals are often younger or capable of increasing amounts of physical rehabilitation. Unfortunately, current ostomy products have not kept pace with the capabilities of modern ostomates. Present ostomy equipment fails to provide for the additional requirements of rehabilitation, long-term health and freedom of physical activity.
Current ostomy appliances consist of three basic components. (1) A faceplate is attached to the body wall around the stoma, generally with the use of adhesives and often with an adjunctive elastic belt. The faceplate usually stays in place from one to six days, depending on the appliance model, the patients skin condition and his level of activity. (2) A receptacle, which is attached to the faceplate, retains the intestinal or urinary waste products after they have passed through the stoma. (3) A drain is used to empty the receptacle when it becomes full.
A number of significant drawbacks are inherent in the designs of currently available ostomy products. These products lack provisions for psychological adjustment, privacy, security, ability to pursue a variety of physical activities, proper hygiene and prevention of infection, protection of the stoma and comfort.
Current ostomy products have not been designed with regard to the psychological adjustment required after ostomy surgery. Individuals dependent upon prosthetic devices including ostomates often have severe difficulty coping with or accepting their physical condition. This is an especially significant drawback for ostomates which may reject or ignore the existence of their ostomies. This self neglect can lead to poor hygiene, illness and diminished sense of self worth. These individuals may also feel that they are incapable of performing many activities of daily living and they therefore needlessly limit themselves.
Ostomy patients are deprived of privacy when wearing a current ostomy product with a thick bulky faceplate bulging through clothing, especially when the faceplate has an uneven external contour making its profile even more obvious. Current ostomy products with bulky drain valves and uneven contours can be uncomfortable against the patient's body and can make additional unsightly bulges in his clothing.
Security is a problem for the ostomy patient because waste products may leak unexpectedly and soil clothing or bedsheets. Most currently available ostomy faceplates are semi-rigid and secured to the surface of the body with adhesives and belts. These belts are narrow, and can curl up and dig into the wearer's skin. Although adhesive technology has improved considerably in the last 25 years, escape of waste products between the faceplate and the surface of the body is still the most common source of leakage in today's ostomy products. Additional leakage can occur between the faceplate and the receptacle, between the receptacle and the drain valve or through weak points in the receptacle.
Ostomy products are generally not designed to allow the pursuit of a variety of physical activities. Many modern ostomates have the physical health to allow them a full and active life. During active physical sports or sexual intercourse, current ostomy faceplates have a tendency to leak and become dislodged from the body wall. Simple activities such as baseball or recquetball can become embarrassing for the ostomate and actually dangerous for his or her stoma. Common daily activities such as wearing a seat belt or closely-tailored clothing can put pressure on the stoma and may be medically harmful when the outflow of waste products is artificially limited because of this external pressure. Experience has shown that this external pressure causes blockage of stoma outflow and may also cause reflux of excreted bodily wastes back into the body. With urostomies this stomal reflux and blockage plays an important role in causing recurrent urinary tract infections.
Current ostomy products also do not provide for easy access to the stoma for proper hygiene and prevention of infection. Chronic or recurrent infections are one of the leading causes of morbidity or illness in a long-term ostomate, especially those individuals with urinary diversions. All types of urostomies excrete mucus with the urinary wastes. This mucus tends to accumulate around the stoma and on the faceplate where, in the presence of urine and body heat, an excellent medium for bacterial growth is created. The concept of daily stoma care is unknown in the ostomy appliance industry and no currently available ostomy products make provisions for daily stoma hygiene. However, there should be daily cleansing of the stoma area when the entire ostomy appliance cannot be removed, as the present invention provides. For urinary diversions, a daily regimen that is designed to disinfect and cleanse the stoma, which is previously unknown, should markedly reduce the occurrence of chronic urinary diversion and upper urinary tract infections. Additionally, in individuals with stomas for elimination of intestinal waste, daily cleansing of the stoma and even enemas should be done.
It is further noted that currently available ostomy products do not protect the stoma from external injury or pressure. The stoma can be injured with relatively small force, and as noted below, during active physical activity there is a marked risk of injury to the stoma. Therefore current activities such as contact or ball sports are dangerous for the ostomate who uses current appliances. The stoma can also be injured accidentally, wile coming in contact with hard or pointed surfaces during routine daily activities.
Comfort and the ability to be comfortable with an ostomy appliance is a major factor for all ostomates. Unfortunately, present ostomy products are remarkably lacking in provision for patient comfort. Comfort for the ostomate is composed of many factors: the internal contour of the faceplate as it fits the body, the external contour of the entire appliance as it appears beneath clothing, the materials used for the appliance, and the adhesives used. Many current ostomy appliance receptacle drain valves are bulky and made of hard materials. These valves can make unsightly bulges or if worn in the groin can cause injury during ordinary daily activities such as bicycling or horseback riding.
Comfort for the ostomate could be provided by custom design of the internal contour of the faceplate. Abdominal wall contour variations have two general categories. The general contour of the general abdominal wall can vary from one individual to another. Also, an individual's abdominal wall contour around the stoma can vary from point to point. The concept of varying the internal contour of an ostomy faceplate from side to side or top to bottom has not yet been pursued by the ostomy appliance industry. This requires a method to determine the variation of contours on each ostomate's abdomen, which the ostomy product industry currently does not have. Current ostomy products also have bulky irregular external contours which bulge through clothing. This is potentially uncomfortable and embarrassing.
Many currently available ostomy products are made of materials lacking in sufficient softness and flexibility for maximum comfort. Improved faceplate flexibility could allow maximal faceplate adherence and minimal leakage. There are no currently available ostomy products which provide optimal comfort via a highly flexible, soft faceplate with streamlined external contours and custom-designed internal contour.
Adhesives have improved since the initial development of ostomy products, but there is no currently available ostomy appliance which protects the stoma, has a smooth external contour and can be attached to the body without the use of adhesives. Adhesives necessitate a lengthy process of preparation for the attachment of the faceplate. Ostomy appliance adhesives and the chemicals required to prepare the skin for their application can cause severe recurrent or chronic irritation of the skin around the stoma, thus making the daily life of the ostomate more difficult and complicated.
In summary, there are many shortcomings and drawbacks among the wide variety of ostomy products currently available. The objects of the present invention are, thus, to improve psychological adjustment, privacy, security, ability to pursue a variety of physical activities, proper hygiene, prevention of infection, protection of the stoma and comfort for those who wear ostomy appliances. The products derived from the present invention will facilitate daily life for the ostomate and allow ostomy appliance wearers to pursue active, fulfilling and productive lives without any significant limitations of activity.
Other objects and advantages of the present invention will become more apparent to those persons having ordinary skill in the art to which the present invention pertains from the following description taken in conjunction with the accompanying drawings.